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STA 5326 mesylate
STA 5326 mesylate is a Small molecule drug developed by Synta Pharmaceuticals Corp.. It is currently in Phase 2 development.
STA 5326 mesylate is a small molecule inhibitor of 1-phosphatidylinositol 3-phosphate 5-kinase. It has been studied in clinical trials for the treatment of Crohn's Disease, Active, Moderate to Severe Rheumatoid Arthritis, and Common Variable Immunodeficiency.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | STA 5326 mesylate |
|---|---|
| Sponsor | Synta Pharmaceuticals Corp. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- STA-5326 Meslylate to Treat Gut Inflammation Associated With Common Variable Immunodeficiency (PHASE1)
- The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's Disease (PHASE2)
- A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue Outcomes (PHASE2)
- Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease (PHASE2)
- Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- STA 5326 mesylate CI brief — competitive landscape report
- STA 5326 mesylate updates RSS · CI watch RSS
- Synta Pharmaceuticals Corp. portfolio CI
Frequently asked questions about STA 5326 mesylate
What is STA 5326 mesylate?
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What development phase is STA 5326 mesylate in?
Related
- Manufacturer: Synta Pharmaceuticals Corp. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing